8/12/2019 29. 11997000738

1/3

Premature rupture of membranes at term: a meta-analysis of three management

schemes

Mozurkewich E L, Wolf F M

Authors' objectivesTo compare rates of Caesarean birth, endometritis, chorioamnionitis, and serious neonatal infections among pregnanciescomplicated by premature rupture of membranes (PROM) at term and managed by immediate oxytocin induction, byconservative management (or delayed oxytocin induction), or by vaginal (or endocervical) prostaglandin E2 gel,suppositories, or tablets.

Searching

MEDLINE (1966 to April 1996, Health (1975 to April 1996, Aidsline (1980 to April 1996) and Cancerlit (1980 to April 1996)and the Cochrane Database for Systematic Reviews (CDSR)(1996 update) were searched. The reference lists of articlesidentified from MEDLINE and CDSR were cross-checked. The search terms used for electronic searches were: 'term','premature rupture' and 'fetal membranes'.

Study selectionStudy designs of evaluations included in the reviewRandomised controlled trials (RCTs). They were classified as either true randomised controlled trials (defined as those inwhich sealed envelopes or random number tables were used), or controlled clinical trials (in which the randomisationmethods were less rigorous or were not detailed). In studies containing both randomised and non-randomised arms, onlydata from the randomised arms were included.

Specific interventions included in the reviewManagement of PROM at term by immediate oxytocin induction, by conservative management (or delayed oxytocininduction), or by vaginal (or endocervical) prostaglandin E2 gel, suppositories, or tablets.

Participants included in the reviewFemales at term gestation (term defined as 36 weeks or more completed menstrual weeks) with rupture of amnioticmembranes before the onset of labour.

Outcomes assessed in the reviewRates of Caesarean birth, endometritis (clinical diagnosis), chorioamnionitis (clinical diagnosis), and serious neonatalinfections (defined as culture-proven neonatal septicaemia, meningitis, or pneumonia).

How were decisions on the relevance of primary studies made?The authors do not state how the papers were selected for the review, or how many of the reviewers performed theselection.

Assessment of study qualityThe studies included in the review were assessed for the quality of their randomisation. The authors do not state how the

papers were assessed for quality, or how many of the reviewers performed the quality assessment.

Data extractionThe following categories of data were extracted: treatment outcomes (Caesarean birth, endometritis, chorioamnionitis,and serious neonatal infections (specifically culture-proven neonatal septicaemia, meningitis, or pneumonia)); location ofstudy; number of participants (by treatment and total); details of initial digital examination; Bishop score; parity; andmethod of treatment assignment. The authors do not state how the data were extracted for the review, or how manyreviewers performed the data extraction.

Methods of synthesisHow were the studies combined?The studies were combined using a quantitative synthesis. Meta-analyses were performed for the various interventionsfor each of outcome of interest using the DerSimonian and Laird (random-effects) technique to estimate the pooled (orcombined) odds ratio (OR) plus 95% confidence interval (CI) for the individual trial results and for the pooled estimates(see Other Publications of Related Interest no.1). Results were confirmed using the Mantel-Haenszel (fixed-effect) pooledOR (see Other Publications of Related Interest no.2).

8/12/2019 29. 11997000738

2/3

How were differences between studies investigated?Homogeneity of ORs across the separate trials pooled in each analysis were tested for significant between-studyvariation. To examine the source of any heterogeneity subgroup analyses were carried out for studies in which theinclusion criteria included unfavourable cervices (Bishop's score less than 5), studies in which no digital examinationswere performed before randomisation, and studies in which digital examinations were performed on all patients beforerandomisation, and separate analyses of RCTs and CCTs.

Results of the reviewA total of 23 studies were included (n=7,493). A total of 3,030 participants had conservative management and delayedinduction; 1,735 had vaginal prostaglandins, 2,722 had immediate oxytocin induction.

The ORs and 95% CIs derived from the random-effects (DerSimonian) analysis are given below by treatment comparisonand by outcome:

Immediate oxytocin versus conservative management: chorioamionitis OR 0.91 (95% CI: 0.51,1.62); endometritis OR0.78 (95%:0.50,1.21; Caesarean birth OR 1.24 (95%CI: 0.89, 1.73), neonatal infection OR 0.73 (95% CI: 0.47, 1.13).

Prostaglandins versus conservative management: chorioamnionitis OR 0.68 (95% CI: 0.51,0.91); endometritis OR 0.81(95%:0.53,1.23; Caesarean birth OR 0.95 (95%CI: 0.76,,1.20), neonatal infection OR 1.06 (95% CI: 0.67, 1.66).

Prostaglandins versus oxytocin: chorioamnionitis OR 1.55 (95% CI: 1.09,2.21); endometritis OR 0.78 (95%:0.23,2.62;Caesarean birth OR 0.67 (95%CI: 0.34,,1.29), neonatal infection OR 1.50 (95% CI: 0.91, 2.45).

Therefore vaginal prostaglandins resulted in more chorioamionitis than immediate oxytocin, but less than conservativemanagement. These results were consistent with those obtained from the fixed-effect analysis, with the exception of theincidences of chorioamnionitis and endometritis in the immediate oxytocin/conservative management comparison

(Mantel-Haenszel pooled ORs, respectively, 0.67, 95% CI: 0.52, 0.85 and 0.71, 95% CI: 0.51, 0.99).

There was significant heterogeneity among the trials pooled for the chorioamionitis outcome (chi-squared (8) =23.99,tau=0.39. p

8/12/2019 29. 11997000738

3/3

Indexing StatusSubject indexing assigned by NLM

MeSHClinical Protocols; Female; Fetal Membranes, Premature Rupture /therapy; Humans; Pregnancy

AccessionNumber11997000738

Database entry date31/01/2001

Record StatusThis is a critical abstract of a systematic review that meets the criteria for inclusion on DARE. Each critical abstractcontains a brief summary of the review methods, results and conclusions followed by a detailed critical assessment onthe reliability of the review and the conclusions drawn.

Database of Abstracts of Reviews of Effects (DARE)Produced by the Centre for Reviews and Dissemination

Copyright 2013 University of York